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Guided Participation Discharge Program for Very Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668912
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Lee Suk Yin, Chinese University of Hong Kong

Brief Summary:
This study aimed at investigating the feasibility of a new guided participation (GP) discharge program for parents of very preterm infants. A randomized controlled trial was conducted in a neonatal intensive care unit. The intervention included three structured GP sessions and one follow-up phone call. The control group received usual care. Outcomes measured included parents' efficacy and satisfaction with parenting, and perceived stress. Data collection was conducted at baseline, on day of discharge, after the follow-up phone call, and 1 month after discharge. The outcomes were analyzed on the basis of intention-to-treat principles.

Condition or disease Intervention/treatment Phase
Very Premature Baby Behavioral: Guided participation discharge programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility of a Guided Participation Discharge Program for Very Preterm Infants
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: Guided participation group Behavioral: Guided participation discharge programme
A nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call)

No Intervention: Usual care group



Primary Outcome Measures :
  1. Parents' change in score of Parenting Sense of Competence Scale from baseline to up to 8 weeks [ Time Frame: Baseline, and at 3-, 4-, and 8-weeks after baseline ]
    The Chinese version of the Parenting Sense of Competence Scale is a self-reported instrument which includes 17 items in two subscales (efficacy and satisfaction). Each item is rated on a 6- point Likert scale ('Strongly disagree' = 1; 'Strongly agree' = 6). Nine items (items 2, 3, 4, 5, 8, 9, 12, 14 and 16) were reverse-coded. The total scores ranged from 17 to 102. A higher score indicates a higher sense of competence and satisfaction with parenting by parents.


Secondary Outcome Measures :
  1. Parents' change in score of Perceived Stress Scale from baseline to up to 8 weeks [ Time Frame: Baseline, and at 3-, 4-, and 8-weeks after baseline ]
    The Chinese version of the Perceived Stress Scale consists of 10 items. Each item is rated on a 5-point Likert scale ('never' = 0; 'very often' = 4). The total score is yielded by summing the scores of all items. The total score ranges from 0 to 40. The higher the score, the higher is the parents' perceived stress in parenting.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For Infants:

Inclusion Criteria:

- A gestational age of ≤32 weeks at birth

Exclusion Criteria:

  • Have congenital malformation(s)
  • Need to undergo a major surgery

For Parents:

Inclusion Criteria:

- Must be the infant's primary caregiver

Inclusion Criteria:

- Diagnosed with a mental illness


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668912


Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: lsy307@ha.org.hk Lee Department of Pediatrics, Prince of Wales Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lee Suk Yin, Principal Investigator, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03668912    
Other Study ID Numbers: 001
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No